Job Description
Are you ready to influence the future of drug development? Nexus BioPharm is seeking a detail-oriented Senior Quality Assurance Specialist to join our elite team in the heart of the Cambridge biotech hub. You will play a pivotal role in ensuring our groundbreaking pharmaceutical products meet the highest global regulatory standards, safeguarding patient safety while driving operational excellence.
We offer a collaborative culture, cutting-edge facilities, and an opportunity to work on life-changing therapies.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in alignment with FDA and EMA regulations.
- Conduct comprehensive internal and vendor audits to ensure strict adherence to cGMP guidelines.
- Manage the investigation of deviations, non-conformances, and CAPAs with a focus on root-cause analysis.
- Review and approve batch production records, validation protocols, and analytical test methods.
- Facilitate cross-departmental collaboration to streamline manufacturing process improvements.
- Lead training initiatives to foster a culture of quality across the production floor.
- Represent the QA department during regulatory agency inspections and internal stakeholder meetings.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 5-7 years of professional experience in pharmaceutical QA/QC or manufacturing.
- Expert knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Strong analytical mindset with proven experience in CAPA management and change control.
- Excellent technical writing and documentation skills.
- Professional certification (e.g., ASQ CQA or similar) is highly preferred.
- Strong communication skills with the ability to lead complex cross-functional projects.